Evaluation of the Possible Effect of Inspiratory Muscle Training on Inflammation Markers and Oxidative Stress in Childhood Asthma

NCT ID: NCT05296707

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2020-06-30

Brief Summary

As inflammation and oxidative stress increase in asthma patients, the severity of symptoms and clinical findings increase. Therefore, this study was planned to evaluate the possible effect of inspiratory muscle training (IMT) on inflammation markers and oxidative stress in childhood asthma.

The study included asthma patient; 35 routine medication, 35 drug therapy and inspiratory muscle training (IMT), and 35 healthy total 105 children aged 8-17 years. Demographic information and hemogram values were recorded. Functional capacity was evaluated with the 6-minute walking test, quality of life PedsQL, respiratory muscle strength oral pressure measuring device, respiratory function test, dyspnea severity with Modified Borg Scale. C-Reactive Protein (CRP), Periostin, Transforming Growth Factor-βeta (TGF-β), Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Oxidative Stress Index (OSI) were analyzed. IMT was given with a Threshold IMT device for 7 days/6 weeks at 30% of maximal inspiratory pressure, and then a second evaluation was made.

Conditions

Asthma in Children; Children, Adult

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Inspiratory muscle training group

Threshold IMT was given this group. Applied for 7 days 6 weeks.

Group Type: EXPERIMENTAL

Inspiratory muscle training

Intervention Type: OTHER

The MIP/MEP value of the group that will receive inspiratory muscle training was determined and Threshold IMT training was given with 30%.

In the training, the subjects were asked to sit in a relaxed position with their upper chest and shoulders relaxed.

After the nose clip was attached, the children were asked to inhale and exhale by tightly closing the mouthpiece of the instrument with their lips.

A 30-minute training session was carried out for 6 weeks, with 10-15 repetitive breathing apparatus and 5-10 seconds rest breaks every day.

Used routine medicine

Intervention Type: OTHER

After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.

Used routine medicine group

Followed 6 weeks

Group Type: ACTIVE_COMPARATOR

Used routine medicine

Intervention Type: OTHER

After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.

Control Group

Health children

Group Type: ACTIVE_COMPARATOR

Control group

Intervention Type: OTHER

A healthy child compatible with the age and sex of the patient group was evaluated once.

Interventions

Inspiratory muscle training

The MIP/MEP value of the group that will receive inspiratory muscle training was determined and Threshold IMT training was given with 30%.

In the training, the subjects were asked to sit in a relaxed position with their upper chest and shoulders relaxed.

After the nose clip was attached, the children were asked to inhale and exhale by tightly closing the mouthpiece of the instrument with their lips.

A 30-minute training session was carried out for 6 weeks, with 10-15 repetitive breathing apparatus and 5-10 seconds rest breaks every day.

Intervention Type: OTHER

Used routine medicine

After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.

Intervention Type: OTHER

Control group

A healthy child compatible with the age and sex of the patient group was evaluated once.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Have been diagnosed with asthma,
• Between the ages of 8-17,
• No asthma attack,
• Cooperating with the study,
• Without cerebral palsy, mental retardation or any other major neurological diagnosis,
• Agreeing to participate in the study,
• Cases whose medication has not been changed for at least three weeks.

Exclusion Criteria

• Presence of kyphoscoliosis that may affect respiration,
• Having advanced postural alignment problem,
• Having mental problems,
• Having neuromuscular disease,
• Making changes in the medications used in the last three weeks,
• Presence of inflammatory diseases such as juvenile idiopathic arthritis.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mustafa Kemal University

OTHER

Sponsor Role: collaborator

Ege University

OTHER

Sponsor Role: lead

Responsible Party

Ozden Gokcek

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ege University

Izmir, Karsıyaka, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Gokcek O, Yurdalan U, Tugay BU, El C, Dogan S. Evaluation of the possible effect of inspiratory muscle training on inflammation markers and oxidative stress in childhood asthma. Eur J Pediatr. 2023 Aug;182(8):3713-3722. doi: 10.1007/s00431-023-05047-4. Epub 2023 Jun 7.

Reference Type: DERIVED

PMID: 37285069 (View on PubMed)

Other Identifiers

2019/16

Identifier Type: -

Identifier Source: org_study_id